New Draft Guidances – List of Highest Priority Devices for Human Factors Review and Applying Human Factors and Usability Engineering to Medical Devices

New Draft Guidances – List of Highest Priority Devices for Human Factors Review and Applying Human Factors and Usability Engineering to Medical Devices

The FDA has issued two related draft guidances. The first provides a list of devices that should have human factors data included in premarket submissions (i.e., for PMA, 510(k)). For the devices on this list, all submissions should provide the FDA with a report that summarizes the human factors or usability engineering processes they have followed, including any preliminary analyses and evaluations and human factors validation testing, results and conclusions.

The second guidance provides the FDA’s recommendations for manufacturers on using human factors and usability engineering processes, as well as the suggested format the Human Factors and Usability Engineering report that needs to be submitted for the devices listed in the first guidance.

Guidance 1 –

List of Highest Priority Devices for Human Factors Review

The FDA has created a list of devices that should have human factors data included in premarket submissions.

  • Ablation generators (associated with ablation systems, e.g., LPB, OAD, OAE, OCM, OCL) OCL)
  • Anesthesia machines (e.g., BSZ)
  • Artificial pancreas systems (e.g., OZO, OZP, OZQ)
  • Auto injectors (when CDRH is lead Center; e.g., KZE, KZH, NSC )
  • Automated external defibrillators (e.g., MKJ, NSA )
  • Duodenoscopes (on the reprocessing; e.g., FDT) with elevator channels
  • Gastroenterology-urology endoscopic ultrasound systems (on the reprocessing; e.g., ODG) with elevator channels Hemodialysis and peritoneal dialysis systems (e.g., FKP, FKT, FKX, KDI, KPF ODX, ONW)
  • Implanted infusion pumps (e.g., LKK, MDY)
  • Infusion pumps (e.g., FRN, LZH, MEA, MRZ )
  • Insulin delivery systems (e.g., LZG, OPP)
  • Negative-pressure wound therapy (e.g., OKO, OMP) intended for use in the home
  • Robotic catheter manipulation systems (e.g., DXX)
  • Robotic surgery devices (e.g., NAY)
  • Ventilators (e.g., CBK, NOU, ONZ)
  • Ventricular assist devices (e.g., DSQ, PCK)

Guidance 2 –

Applying Human Factors and Usability Engineering to Medical Devices

This guidance recommends that manufacturers follow human factors or usability engineering processes during the development of new medical devices, focusing specifically on the user interface, where the user interface includes all points of interaction between the product and the user(s) including elements such as:

  • Displays
  • Controls
  • Packaging
  • product labels
  • Instructions for use, etc.
  • CDRH recommends that manufacturers consider human factors testing for medical devices as a part of a robust design control subsystem

Three steps for performing a successful human factors engineering (HFE) and usability engineering (UE) analysis:

  1. Identify anticipated use-related hazards and initially unanticipated use-related hazards (derived through preliminary analyses and evaluations), and determine how hazardous use situations occur
  2. Develop and apply measures to eliminate or reduce use-related hazards that could result in harm to the patient or the user
  3. Demonstrate whether the final device user interface design supports safe and effective use by conducting human factors validation testing
Alyssa Woodcock
awoodcock@boston-biomedical.com

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